Process validation instructor and subject matter expert

  • 医療用品
  • エンジニア

経験内容

10 years of experience providing instruction in process validation for medical devices. Courses offered are introduction to process validation, installation qualification and equipment operational qualification, process operational qualification, and performance qualification.
With a team of process validation instructors, we created course content and curriculum, ensuring that it is compliant with cGMPs and our quality management system,
Also available for consultation on the writing and execution of process validations within the organization.

氏名・職歴の開示について

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職歴:(開示前)


自己紹介

Process and Quality Engineering for Class III PMA medical devices and combination devices from early stage R&D through commercialization. Experience includes process and equipment validations, design control, risk management, and automation.

Specialties: Design of Experiments, Monte Carlo simulation, metrology, R, JMP, JMP Scripting, ISO 13485, NPD, R&D, video inspection systems, cGMP, LaTeX, Combination Products, Drug Delivery, Raw Materials, Specifications, Test Method Validation, Process Validation

職歴

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